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Form 483

Torrent Pharmaceuticals Limited Form 483, 2016-05-20

FDA issued a Form 483 to Torrent Pharmaceuticals Limited on 2016-05-20 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Torrent Pharmaceuticals Limited · Indrad, India · Issued May 20, 2016

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

20 May 2016
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Cheryl A Clausen

20 May 2016
21 CFR 211.84(c)(4)

Top/Middle/Bottom container sampling

Cited by Cheryl A Clausen

20 May 2016
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Cheryl A Clausen

20 May 2016
21 CFR 211.84(c)(4)

Top/Middle/Bottom container sampling

Cited by Cheryl A Clausen

Inspected site

TPTorrent Pharmaceuticals LimitedIndrad, India

Inspection team

CACheryl A Clausen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.84(c)(4)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere